Here are three questions that are sure to spark conversation.ġ. And the film raises important questions about the medical device approval process, financial incentives and more. While medical device manufacturers and clinical researchers will no doubt have strong opinions about the film, millions of patients will likely watch it. A company spokesman pointed out the obvious ethical problems with running randomized or non-blinded trials and having a control group that would be subjected to invasive laparoscopic tubal ligation surgery. “The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades,” Bayer stated in a news release.īayer also went on defense in a recent Variety article, criticizing the filmmakers for a lack of understanding about the science and ethics behind medical device trials. Just days before its release, Bayer announced it would stop selling Essure - the permanent birth control device profiled in the documentary - by the end of the year.īayer cited a decline in sales due to other birth control options and “inaccurate and misleading publicity about the device,” rather than patient safety concerns. The filmmakers interview physicians, regulators and others who point to a flawed process for medical device approvals, kickbacks for physicians and other contributing factors.

Doctors were unable to fully remove the mesh, and as a result of complications, she is no longer able to have sexual intercourse with her husband. A woman experiences chronic pain after having a pelvic mesh treatment to improve bladder control.He tests his own blood and discovers the amount of cobalt in his system is 100 times greater than normal due to the disintegration of the joint replacement. An orthopedic surgeon has a chrome-cobalt hip replacement and later experiences serious neurological issues, including tremors, memory loss and a psychological breakdown in which he vandalizes a hotel room.Using Facebook groups, she finds thousands of other women who all say they’ve experienced similar problems after having the device implanted. A woman suffers painful cramps, headaches and other problems she believes are due to complications from a permanent birth control device.The Bleeding Edge, produced by Academy-Award nominated filmmakers Kirby Dick and Amy Ziering, tells the stories of patients who say they’ve suffered serious health problems as a result of recent medical devices being used in their procedures. Medical devices have undoubtedly improved the quality of life for millions of people, too.īut a provocative new Netflix documentary raises an important question: Is there a point when innovation goes too far? Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Sandra Maddock, president and CEO, IMARC Research

The bleeding edge hip replacement